DRAGON PAIN RELIEF- menthol, unspecified form, camphor, (-)-, and methyl salicylate cream 
Genomma Lab USA

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Dragon® Pain Relief Cream

Drug Facts

Active ingredients

Camphor 4%, Menthol 10%, Methyl salicylate 30%

Purpose

Topical analgesics

Uses

Temporarily relieves the minor aches and pains of muscles and joints associated with:

Warnings

For external use only

Allergy alert

  • If prone to allergic reaction from aspirin or salicylates, consult a doctor before use.

Do not use

  • on wounds or damaged skin
  • with a heating pad
  • on a child under 12 years of age with arthritis-like conditions

Ask a doctor before use if you have redness over the affected area.

When using this product

  • do not use otherwise than as directed
  • avoid contact with eyes or mucous membranes or rashes
  • do not bandage tightly

Stop use and ask a doctor if

  • redness is present or irritation or rash develops
  • conditions worsen or symptoms persist for more than 7 days
  • symptoms clear up and occur again within a few days

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center immediately (1-800-222-1222) right away.

Directions

Adults and children 12 years of age and older: apply to affected area not more than 3 to 4 times daily

Children under 12 years of age: ask a doctor

Other information

Inactive ingredients

ethylparaben, glyceryl monostearate, polysorbate 80, purified water, sorbitan monooleate, stearic acid

Questions or comments?

Call toll free 1 877 994 3666.

Monday to Friday 8:00 am – 6:00 pm CST

Distributed by:
Genomma Lab USA, Inc., Houston, TX 77027

PRINCIPAL DISPLAY PANEL - 56.7 g Tube Carton

POMADA
DRAGON®
ULTRA STRENGTH

PAIN RELIEF CREAM

FAST RELIEF OF MUSCLE,
BACK AND JOINT PAIN

Deep Penetrating
Fast Acting Relief

NET. WT 2.0 oz (56.7 g)

PRINCIPAL DISPLAY PANEL - 56.7 g Tube Carton
DRAGON PAIN RELIEF 
menthol, unspecified form, camphor, (-)-, and methyl salicylate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50066-412
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM100 mg  in 1 g
CAMPHOR, (-)- (UNII: 213N3S8275) (CAMPHOR, (-)- - UNII:213N3S8275) CAMPHOR, (-)-40 mg  in 1 g
methyl salicylate (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) methyl salicylate300 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
glyceryl monostearate (UNII: 230OU9XXE4)  
Water (UNII: 059QF0KO0R)  
Polysorbate 80 (UNII: 6OZP39ZG8H)  
sorbitan monooleate (UNII: 06XEA2VD56)  
stearic acid (UNII: 4ELV7Z65AP)  
ethylparaben (UNII: 14255EXE39)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50066-412-021 in 1 CARTON08/13/2021
156.7 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34808/13/2021
Labeler - Genomma Lab USA (832323534)

Revised: 8/2021
Document Id: 010331fb-8731-4ec9-ab95-9110e69886e5
Set id: 40c1a66f-a21f-4f81-a072-3bdd1a612ad8
Version: 1
Effective Time: 20210816
 
Genomma Lab USA